COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE

Cannabis Abuse Clinical Trial

Official title:

COGNITIVE BEHAVIORAL THERAPY PROGRAM TO FIRST-EPISODE PSYCHOSIS PATIENTS AND CANNABIS ABUSE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319746
• Other study ID #: COG-CON
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: September 2019

Study information

• Verified date: January 2020
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

General objective:

To assess the effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users.

Design A multicenter single-blind randomized study with 1 year of follow-up. The effectiveness of a treatment program specific for cannabis abuse (cognitive behavioral treatment + pharmacological treatment) compared to standard treatment (pharmacological treatment + psychoeducation) in patients with first episodes psychosis (FEP) cannabis users will be assessed.

Patients will be randomly assigned to one of two treatments:

1. Experimental group (N=50): Cognitive-behavioral treatment specific for cannabis abuse + pharmacological treatment

2. Control group (N=50): standard treatment: psychoeducation + pharmacological treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

1. - Having a first psychotic episode. DSM-IV-TR diagnosis of a psychotic disorder (i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, bipolar disorder, atypical psychosis, brief psychotic disorder, or major depressive disorder with psychotic symptoms).

2. - Being a regular cannabis user according DSM-IV

3. -Being in remission from the first psychotic episode (not exceeding 5 years).

Exclusion Criteria:

1. Presenting organic brain pathology.

2. Presenting mental retardation according to DSM-IV criteria.

Related Conditions & MeSH terms

• Cannabis Abuse
• First-episode Psychosis
• Marijuana Abuse
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse
The intervention program is focused on reducing the cannabis use, improving awareness of illness, adherence to treatment, identification of prodromes, psychosocial functioning improvement and relapse prevention.
• Psychoeducation
The aim of psychoeducation is that the patient understands and be able to manage the disease providing the tools and skills to symptoms management, to avoid relapse and contribute to their wellbeing.

Locations

Country	Name	City	State
Spain	Araba University Hospital	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannabis use reduction in the follow-up	To assess whether cannabis focused psychological intervention is associated with a cannabis use reduction according to Europ-ASI scale compared to standard treatment	Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up.
Primary	Improvement in the development of psychotic disorder	To assess whether cannabis focused psychological intervention is associated with an improvement in the development of psychotic disorder (ie, reduction of symptoms and improvement of psychosocial functioning) compared with standard treatment at the end of treatment and at follow-up (at three and six months and one year of follow-up).	Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Primary	Changes in the components of the endogenous cannabinoid system	To determine whether changes in the components of the endogenous cannabinoid system at systematic level are produced in FEP cannabis abusers.	Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Primary	Normalizing the possible alterations in the endogenous cannabinoid system	To assess whether treatment program specific for cannabis abstinence is capable of normalizing the possible alterations in the endogenous cannabinoid system in patients that reduce the cannabis use.	Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Secondary	Decrease the number of cannabis users	To determinate the number of patient who use cannabis in the follow-up in each group	Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Secondary	Decrease of negative and positive psychotic symptoms	To compare the decrease of negative and positive psychotic symptoms measured by Positive and Negative Syndrome Scale (PANSS), at post-treatment and follow-up.	Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Secondary	Decrease of manic, depressive and anxiety symptoms	To compare the decrease of manic, depressive and anxiety symptoms at post-treatment and follow-up. Manic symptoms will be measured using Young Mania Rating Scale (YMRS). Anxiety and depressive symptoms will be measured using Hamilton Anxiety Scale (HAM-A) and Hamilton Depression Scale (HAM-D), respectively.	Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Secondary	Improvement in the psychosocial functioning	To compare the improvement of psychosocial functioning in each group by Functioning Assessment Short Test (FAST).	Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Secondary	Improvement in the adherence to pharmacological treatment	To compare the adherence to pharmacological treatment in each group using Morisky-Green Scale.	Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Secondary	Withdrawal of patients	To evaluate percentage of withdrawal in the follow-up.	Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up
Secondary	Decrease the number of relapses and rehospitalizations	To compare the number of relapses and rehospitalizations in in each group.	Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up